Brain Metastases From Breast Cancer, Breast Cancer, Metastatic, Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Quality of Life, Leptomeningeal Metastasis of Breast Cancer
Conditions
Keywords
Quality of Life
Brief summary
Central nervous system (CNS) metastases including breast cancer brain metastases (BCBMs) and leptomeningeal disease (LMD) are common affecting up to 30% of patients with metastatic breast cancer (MBC). The goal of this research is to understand symptom burden and quality of life trajectories in this population and how treatments guide care management decisions.
Detailed description
PRIMARY OBJECTIVE: I. To describe overall symptom experience and quality of life (QOL) over time in breast cancer patients with brain metastases and/or leptomeningeal disease. SECONDARY OBJECTIVES: I. To evaluate the impact of cancer-directed treatments over time on quality of life, physical function, and cognitive function in patients with breast cancer brain metastases and/or leptomeningeal disease including: * The impact of whole brain radiation versus stereotactic radiosurgery on QOL. * The impact of brain metastasis surgical resection on QOL. * The impact of CNS-penetrant systemic therapies on QOL. * The impact of craniospinal irradiation and other treatment modalities for LMD on QOL. EXPLORATORY OBJECTIVES: I. To evaluate the interaction between QOL and demographics, social determinants of health, and control of systemic disease in patients with breast cancer brain metastases and/or leptomeningeal disease. OUTLINE: Participants will be given questionnaires and followed for at least 3 years but may withdraw at any time.
Interventions
OTHERHealth-Related Quality of Life (QOL) questionnaires
Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
OTHERMedical Chart Review
Data will be collected from the participants electronic medical record
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be male or female 18 years of age or older. 2. Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and/or leptomeninges. 3. Have the intention to start or continue anticancer therapy. 4. Be able to provide informed consent. 5. Be able to speak and read English.
Exclusion criteria
Participants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall changes in reported symptom burden | Every 3 months for up to approximately 5 years. | Participants will complete the 22-item MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the severity of various symptoms related to cancer (13 items) and symptoms specifically related to brain cancer (9 items) during the last 24 hours. Participants responses are given on a scale from 0 (not present) to 10 (worst possible). The higher the score the more severe the symptom. A subset of the most prevalent or severe symptoms reported will be used to represent symptom burden. Additional information on the questionnaire development scoring and copyright details can be found at https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/md-anderson-symptom-inventory-brain-tumor.html |
| Frequency of moderate to severe symptoms | Every 3 months for up to approximately 5 years | Participants will complete the 22-item MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the severity of various symptoms related to cancer (13 items) and symptoms specifically related to brain cancer (9 items) during the last 24 hours. Participants responses are given on a scale from 0 (not present) to 10 (worst possible). The higher the score the more severe the symptom. The frequency of responses to the MDASI-BT items with a score of 4 or higher will be reported as a percentage of the total number of participants. |
| Overall change in scores on reported symptom interference (MDASI-BT) | Every 3 months for up to approximately 5 years | Participants will complete the 6-item section of the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the interference of cancer symptoms during the last 24 hours. Participants responses are given on a scale from 0 (no interference) to 10 (interfered complete) and address general activity, mood, work/housework, relationships, walking, and enjoyment of life. The higher the score the more the symptom interfered with daily life. Additional information on the questionnaire development scoring and copyright details can be found at https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/md-anderson-symptom-inventory-brain-tumor.html |
| Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Cognitive Function Short Form 8a Questionnaire over time | Up to 5 years. | This 8-item questionnaire to measure cognitive function based on responses to statements about how the participants feel regarding various cognitive tasks in the past 7 days with responses ranging from 5="Never" to 1="Very Often", and a total raw score ranging from 8 - 40, which are converted to a scaled T-score (range 22.41 to 63.48) with lower scores indicating a greater impairment of cognitive function. |
| Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function Questionnaire over time | Every 3 months for approximately 5 years. | This 6-item questionnaire to measures self-reported capability to physically function in the context of cancer and/or cancer treatment experiences, based on responses to statements about how the participants feel regarding various physical tasks in the past 7 days with responses ranging from 5="Without difficulty" to 1="Unable to do", or 5="Not at all" to 1="Cannot do" and a total raw score ranging from 6 - 30, which are converted to a scaled T-score with a range from 20.8 -59), with lower scores indicating a greater impairment of physical function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen | Up to 5 years | The overall changes in scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function scores by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models. |
| Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen | Up to 5 years | The overall changes in scores on both the PROMIS physical function scores by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models. |
| Changes in MDASI-BT scores over time by non-investigational treatment regimen | Up to 5 years | The overall changes in scores on the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models. |
Countries
United States
Contacts
CONTACTAmy Langdon
PRINCIPAL_INVESTIGATORLaura Huppert, MD
University of California, San Francisco
PRINCIPAL_INVESTIGATORMichelle Melisko, MD
University of California, San Francisco
Outcome results
None listed